sTPA and Appropriate documentation for

contraindications: A conversation with The Joint Commission and a Physician

Perspective

Shyam Prabhakaran, MD, MS

Rush University Medical Center

11/7/08

s

Source: JAMA, 2000;283:3102-3109 Recommendations for the Establishment of Primary Stroke Centers

Acute Stroke Care • Rapid, accurate

assessment• Imaging protocols• Guideline based order

sets, protocols, and pathways

• Quality and outcome monitoring

sDSC/Stroke-4: Tissue Plasminogen

Activator (t-PA) ConsideredMeasure: All patients who present at a hospital

with symptoms of an ischemic stroke with symptom onset of 3 hours or less should be considered to receive intravenous (IV) t-PA

Rationale: The administration of thrombolytic agents to carefully screened, eligible patients with acute ischemic stroke has been shown to be beneficial in some recent clinical trials. IV t-PA is the only FDA approved treatment for acute ischemic stroke.

sAcute Stroke Evaluation:

60 Minute or Less Protocol• Triage – 10 minutes: Patient compliant, focused history,

vital signs, GCS, ECG• ED Physician – 10 to 20 minutes: Focused history and

physical exam, laboratories, CT Scan-codes stroke (Goal: 25 minute door-to-CT)– Vital sign monitoring, neurologic checks, seizure and aspiration

precautions

• Neurology Consult – 20-30 minutes: Review history, physical exam, review CT Scan

• Treatment Decisions

s

Door to IV TPA Goal < 60 Minutes

=

Time is Brain

• STARS Registry– 38 community, 18 academic hospitals, 389 IV TPA pts– Median door to needle time: 96 minutes

• CDC 4 State Pilot Acute Stroke Registry– 98 hospitals, 6867 acute patients, 118 IV TPA– Treatment within target 60 minutes: 14.4%

Stroke Onset to IV TPA < 3

hours

sDifferential Diagnosis

• Ischemic Stroke• Hemorrhagic Stroke• Trauma• Meningitis/Encephalitis• Mass

– tumor– subdural hematoma

• Seizure: post-ictal

• Metabolic– hyperglycemia– hypoglycemia– post-cardiac arrest– drug overdose

sCT Results

sStrategies in Acute Ischemic Stroke

• Proven– Supportive Care:

– Treat hypoxia

– Maintain normothermia

– Avoid hyperglycemia

– Early parental fluids and permissive hypertension

– Recanalization (Thrombolytics < 3 hours)– Prevent Clot Propagation– Early Implementation of Secondary Prevention

sNIH/NINDS tPA study

Design

Randomized, double-blind placebo-controlled trial

Raters different from baseline examiners

Two parts

Part 1: 24-hour improvement

• Complete resolution of deficit or improvement of 4 points on the NIH stroke scale

Part 2: 3-month outcome

• Consistent and persuasive difference in proportion of patients with minimal or no deficit

sEligibility Criteria

• Ischemic stroke with clearly defined time of onset < 3 hours

• Baseline CT negative for hemorrhage

• Age > 18 years

• Moderate to severe symptoms

sTreatment

Dose 0.9 mg/kg (maximum 90 mg)

10% given as IV bolus

90% constant IV infusion over over 1 hr

Other meds No other anticoagulants or antiplatelet agents for 24 hours post tPA

Strict BP control (< 180/105 mmHg) post-tPA

s• >18 y.o. with ischemic stroke < 3 hours

• Moderate or severe symptoms

• Coagulation status

– If patient has received recent anticoagulation therapy: PT < 15 sec. and normal PTT

– Platelets > 100,000

• Blood Pressure SBP<185mmHg, DBP <110

• Glucose > 50 mg/dl

Thrombolytic Therapy Checklist

Adams HP, et al. ASA Stroke Council. Stroke. 2003;34:1056-1083.

sOther exclusion criteria

• Prior stroke or head trauma within 3 months

• Major surgery within 14 days

• History of ICH or SAH

• GI or GU hemorrhage within 21 days

• Arterial puncture at non-compressible site within 7 days

• Lumbar puncture within 7 days

• Rapidly improving or mild symptoms

• Seizure at stroke onset

• SBP > 185 or DBP > 110

• Glucose <50 or >400 mg/dL

• Any oral anticoagulants

• Elevated PT > 15s or PTT > 1.5x normal

• Platelet count < 100,000

sNINDS TPA Stroke Trial

Global outcome statistic: OR=1.7, 50% v. 38%= 12% benefit

Excellent outcome at 3 months on all scales

52%

38%43%

26%

45%

31%34%

21%

0%

10%

20%

30%

40%

50%

60%

BarthelIndex

RankinScale

GlasgowOutcome

NIHSSscore

TPA

Placebo

s• Benefit at 3 months

– 55% more likely to be neurologically normal

• 12% absolute benefit

• NNT is 8

– 60-70% more likely to have favorable outcome

• Risk of sICH is 6.4%

– Overall benefits include ICHsAdams HP Jr. Stroke 2003;34:1056-1083.

sNumber Needed to Treat to Benefit from IV TPA

Across Full Range of Functional Outcomes

Outcome NNT

Normal/Near Normal 8.3

Improved 3.1

For every 100 patients treated with tPA,

32 benefit, 3 harmed

Stroke 2007; 38:2279-2283

s

Marler JR et al. Neurology 2000;55:1649-55.

s

• Efficacy similar to NINDS trial

• Rate of ICH: 4%-6%

• Risk of ICH increases with protocol violations– Time >3 hours– Poor blood pressure control– Using prohibited agents– Wrong dose

• 0.9 mg/kg• Maximum dose: 90 mg

– Elevated blood sugar also increases risk

Adams HP, et al. ASA Stroke Council. Stroke. 2003;34:1056-1083.

Use of tPA in Routine Clinical Practice

s• Only 1.8-2.4% of stroke patients review IV tPA• Reasons for exclusions

– Delayed patient arrival (>3 hrs)– In-hospital delays in completion of required tests prior

to rt-PA administration – Presence of exclusion criteria– Physician reluctance to administer the drug due to

inexperience, unavailability of neurological consultation, or fear of medical complications or legal ramifications

s#1 Reason for IV TPA exclusion: Delay to ER 73%

Only 27% of those presenting within 3 hours were treated with IV TPA Of those presenting <3 hours (n=314):1. Rapid improvement 18%2. Mild symptoms 13%3. Protocol exclusion 14%4. Delay in ER 9%5. Comorbidity 8%

Barber PA, et al. Neurology 2001;56:1015-1020.

sRecommendations for appropriate use of tissue

plasminogen activatorKey elements

– Acute stroke teams

– Written care protocols

– Integrated emergency response system and infrastructure for hyperacute evaluation

– Documentation checklist

– Quality improvement programs

JAMA, June 21, 2000-Vol 283, No. 23

sAcute Stroke Team

• Dedicated pager: “Stroke Code”• Arrival at bedside within 15 minutes• Protocols/standing orders in place for all stroke patients:

– Written stroke protocols for IV tPA associated with fewer complications

– Post treatment care pathways (BP control after tPA)

• Stroke team members– Stroke neurologist– Emergency room physician– Residents (if applicable)– Nurses– Radiologist and technicians– Pharmacist

sHospital Logistics

• Neuroradiology– CT available 24 hours a day– Completed within 25 minutes– Read within 45 minutes

• Laboratory services– Results of CBC, BMP, coags back within 45 minutes

• Family, patient, staff, and EMS education• Data collection and performance improvement• Community outreach and education• Institutional support and leadership

sNOTICE: CHANGE IN THE

NEUROLOGY PAGER* 85-7800 is the new pager for Neurology

Use this pager to reach neurology for consults (routine and urgent), for questions to neurology, etc…

85-4500 is now the Acute Stroke Pager

Use this pager for suspected acute stroke (i.e. stroke onset < 12 hours) Use of this pager will activate the acute stroke team

*These changes will be effective on January 2, 2007

Acute Stroke Pager

sRUMC ALGORITHM ACUTE STROKE (ED)

Clinical Suspicion of ACUTE STROKE < 12 Hours from onset

a) New neurological deficit (weakness, numbness, change in vision, change in speech, clumsiness, trouble walking)

ORb) Acute decrease in level of consciousness

ORc) Worst headache of life

Emergency Department

Activate Acute Stroke Pager (85-4500) Notify ED attending Vital signs and finger stick Place 2 large bore peripheral IV’s, NPO Labs (with special label):

- CBC, PT/PTT, - Chem7, troponin

- Type & holdUrine HCG (pre-menopausal women)Notify Radiology technician (26874)STAT Head CT (done w/i 25 min)Neurologic exam/determine onset timeObtain 12-lead ECG, pulse oxGive supplemental O2 for Sp02<93%Obtain chest X-Ray STATAlert pharmacy if tPA eligible

Acute Stroke Team

At bedside within 15 minutes of page.Confirm time of onset (last known normal)Obtain Past Med Hx

- Prior ICH or SAH- Known cerebral AVM, aneurysm, tumor- Recent trauma or surgery- Review current medications

Check vital signs (review BP)Perform NIHSSReview Head CT (read by 45 minutes of arrival)Review available lab tests (gluc, plts, coags)Discuss with Stroke Attending

INITIATE TREATMENT

s

Stroke Labs

sAcute stroke labs and CT compliance

0

20

40

60

80

100

Month

Pe

rce

nta

ge

Labs under 45 minutes CT under 25 minutes

Jan Feb Mar Apr May Jun Jul

Stroke lab protocol change 3/17/07

CT protocol change 2/1/07

s

s

s

Evaluate AssessmentReview Summary

Reports

Implement Refined ProtocolCoordinate Implementation of

Refined Protocol

Assess Stroke Treatment RatesAnalyze Process from ED to

Discharge, Rates of TPA Use, Other Standards of Care

Refine ProtocolIdentify

Areas for Improvement

s• Goal door-to-treatment time < 60 minutes and

reduce treatment-related complications• Continue to review outcomes following acute

stroke interventions– Monthly meetings– Continue to improve CT and lab times– Chart review for protocol violations and

documentation errors

• Re-educate staff members on protocols– Emails– Staff meeting presentations– In-services

– Stroke champion